NCT07299019 A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
| NCT ID | NCT07299019 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Zenas BioPharma (USA), LLC |
| Condition | Secondary Progressive Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 990 participants |
| Start Date | 2026-03-23 |
| Primary Completion | 2030-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 990 participants in total. It began in 2026-03-23 with a primary completion date of 2030-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with non-active Secondary Progress MS. Patients will be treated for approximately 24 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.
Eligibility Criteria
Inclusion Criteria: 1. 18 to 60 years of age, inclusive, at the time of signing the informed consent. 2. Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald criteria 3. Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013 4. Participant must have documented evidence of disability progression independent of clinical relapse observed during the 24 months before screening. A written summary of the clinical evidence of disability progression must be discussed and aligned between the Investigator and the Sponsor's dedicated qualified person(s). 5. Absence of clinical relapses for at least 24 months. Exclusion Criteria: 1. The patient has been diagnosed with primary progressive MS (PPMS) according to 2024 McDonald diagnostic criteria 2. Immunologic disorder other than MS or any other conditions requiring corticosteroid therapy. 3. History or current diagnosis of other neurological disorders that may mimic MS 4. History or current diagnosis of progressive multifocal leukoencephalopathy 5. Active, clinically significant viral, bacterial, or fungal infection 6. History of any other significant active medical condition 7. History of suicidal behavior within 6 months prior to Screening 8. Any prior history of malignancy 9. Patients on anticoagulation, or antiplatelet therapy 10. Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducers within 14 days 11. Clinically significant laboratory abnormalities at Screening. 12. Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening 13. History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07299019 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Secondary Progressive Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07299019 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 990 participants.
Is NCT07299019 currently recruiting?
Yes, NCT07299019 is actively recruiting participants. Contact the research team at clinicaltrialsinfo@zenasbio.com for enrollment information.
Where is the NCT07299019 trial being conducted?
This trial is being conducted at Phoenix, United States, Scottsdale, United States, Fullerton, United States, Torrance, United States and 11 additional locations.
Who is sponsoring the NCT07299019 clinical trial?
NCT07299019 is sponsored by Zenas BioPharma (USA), LLC. The trial plans to enroll 990 participants.
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